Kornimate/medical-research-clean huggingface dataset:
role of growth hormone antagonism in modulating insulin sensitivity in subjects with pre-diabetes

Conditions: Diabetes; Metabolic Syndrome; Insulin Resistance

Summary: growth hormone is well known to cause changes in glucose regulation. people with laron syndrome are born without the growth hormone receptor and are protected from diabetes. mice who are engineered without the growth hormone receptor are similarly protected from diabetes. conversely, people who have excessive amounts of growth hormone, such as patients with acromegaly, have an increased risk for type 2 diabetes. in acromegaly patients, treatment with pegvisomant, a medication that reduces insulin like growth factor-1 by blocking the growth hormone receptor, significantly improves insulin resistance. pegvisomant has not been explored as a possibility for the treatment of type 2 diabetes or insulin resistance in people without acromegaly. in this study, the investigators hope to study the metabolic effects of pegvisomant on people who have insulin resistance but not diabetes. pegivosmant is expected to improve insulin resistance in the liver, fat and muscle as well as decrease serum free fatty acids.


Eligibility criteria:
inclusion criteria: * bmi between 18-35 * homeostatic model assessment - insulin resistance (homa-ir) \>2.77 * able to administer daily subcutaneous injections of pegvisomant exclusion criteria: * pregnancy * breastfeeding in the last 6 months * liver function tests greater than 3x the upper limits of normal * unstable diet over the last 3 months * unstable weight over the last 6 months * unstable lipid lowering regimen * diabetes - type 1 or type 2 * history of major gastrointestinal surgery * history of pancreatic, liver, biliary, or intestinal disease * fasting blood glucose \>126 * fasting triglycerides\>500 * a1c\>6.5

Keywords: growth hormone antagonism
nebulized hypertonic saline for bronchiolitis

Conditions: Bronchiolitis

Summary: this study aims to examine the effect of nebulized 3% hypertonic saline in the treatment of viral bronchiolitis. the investigators hypothesize that nebulized 3% saline will decrease rate of hospital admission, decrease clinical severity scores, and decrease length of stay.

bronchiolitis is the most common viral respiratory infection in young children and infants. it is responsible for hundreds of thousands of outpatient visits and hospitalizations every year. hypertonic saline may decrease swelling in the lung tissue, improve the patient's ability to clear secretions, and decrease nasal congestion. hypertonic saline nebulizations have already been used effectively in patients with cystic fibrosis and in a few small trials on infants with bronchiolitis. patients who come to the emergency department or inpatient ward of two urban free-standing pediatric hospitals in california between december and april and are diagnosed with bronchiolitis will be randomized into two groups- the control group will receive nebulized 0.9% normal saline, while the study group will receive nebulized 3% hypertonic saline. nebulizations will be pretreated with albuterol, to prevent the theoretical risk of increased wheezing in patients with undiagnosed underlying asthma. patients will be given up to 3 nebulizations in the emergency department, after which time the attending physician will decide whether admission to the hospital is required. patients who are admitted will continue to receive the same nebulized treatment every 8 hours until discharged. additional interventions such as epinephrine treatments and antibiotics can be ordered as indicated by the patient care team. investigators will measure symptom severity before and after treatments using the respiratory distress assessment instrument (rdai). the investigators will compare rates of being admitted to the hospital in each group. the investigators will also compare rdai scores, average length of stay, number of additional respiratory treatments needed, number of hours requiring oxygen, amount of iv fluid needed, and frequency of adverse effects. the investigators hypothesize that nebulized hypertonic saline will be a safe, cost-effective, and efficacious therapy which can be utilized in the outpatient setting to prevent hospital admission, as well as decrease length of stay for patients who require admission. given the significant disease burden of viral bronchiolitis, the potential impact is substantial.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of viral bronchiolitis * between november and april exclusion criteria: * prematurity \< 34 weeks * chronic lung disease * congenital heart disease * history of wheezing, asthma or albuterol use * tracheostomy status * need for intensive care of assisted ventilation

Keywords: bronchiolitis hypertonic saline
the effect of chiropractic manipulation on spine-related pain and balance in older adults

Conditions: Musculoskeletal Equilibrium; Back Pain

Summary: the effect of chiropractic manipulation on spine-related pain and balance in older adults.

chronic pain and risk factors for falls in older adults are significant public health issues. in order to evaluate an appropriate role for chiropractic in managing these problems in the population, this pilot cohort study will take multiple measurements, both self-reported and functional, on a sample of older adults with chronic spine-related pain who are recruited from the local community and receive chiropractic care in the cleveland chiropractic college health center over a four-week period.

Eligibility criteria:
inclusion criteria: 1. aged 60 or older 2. spine-related pain of \>3 months duration (by self-report). exclusion criteria: 1. non-ambulatory 2. chiropractic care or physical therapy within the past month (by self report) 3. contraindications to manipulation, as determined by the clinician through physical exam and x-rays (if indicated) 4. absence of indications for cmt, as determined by the clinician through history, physical exam, orthopedic tests, and static and motion palpation 5. unable to understand english adequately to complete study forms.
failure of chronically implanted defibrillator leads -incidence and management

Conditions: Death, Sudden, Cardiac; Ventricular Fibrillation

Summary: comparison of two different approaches to address the problem of malfunctioning icd-leads. these leads consist of two parts. one that is used for detection of arrhythmias(and pacing if required) (pace/sense) and a second part that is used to deliver therapy is needed (shock-coil). the two approaches compared are: replacement of the entire lead in case of any lead malfunction versus placement of an additional pace/sense-lead if the shock-coil of the exiting lead was still functional.

therapy with an implantable cardioverter defibrillator (icd) has become a standard treatment for an increasing number of patients suffering from different types of heart diseases which can lead to fatal arrhythmias. this therapy was established about 20 years ago and malfunctioning electrodes of these devices have been, and still are a serious problem leading to inappropriate therapy (shocks)or missed live saving therapy. in case of a malfunctioning electrode it is established clinical practice to either replace the entire icd electrode (which is used for detecting the arrhythmias as well as delivering the shock) or just to implant an additional electrode for detection of the arrhythmia (and pacing if required) given that the "shock"-part of the existing electrode is still functional. there is no longterm outcome data comparing these two strategies. we included 1317 consecutive patients with an icd implanted at three european centers between 1993 and 2004. incidence of lead failure, type of lead used, approach and outcome were evaluated.

Eligibility criteria:
inclusion criteria: * implantation of an icd between 1993 and 2004 exclusion criteria: * none

Keywords: implantable cardioverter defibrillator lead failure pace/sense lead icd complication inappropriate therapy defibrillators
establishment of a decision aid tool for asymptomatic small leiomyoma and analysis of influencing factors for clinical decision-making using hifu

Conditions: Leiomyoma, Uterine; High-Intensity Focused Ultrasound Ablation; Patients Decision Aids

Summary: with the younger patients diagnosed with asymptomatic leiomyoma, delay in the reproductive age of women, the advancement of medical technology, and the rapid development of treatment methods, there are many choices between gynecologists, gynecologists and patients because of experience and knowledge. it is not easy to make the most favorable choice for patients. this study is mainly led by a committee composed of designers, doctors, nurses and patients, and based on clinical guidelines and evidence-based medicine. co-operating with patients with asymptomatic small leiomyoma, we want to find the influencing factors of clinical decision-making, and to establish a patient decision aid tool. we use prospective trial to verify that the use of this tool can improve patients' decision-making efficacy and further improve patient-reported outcomes.


Eligibility criteria:
inclusion criteria: 1. diagnosis of leiomyoma: patients with leiomyoma diagnosed by imaging examinations (ultrasound and mri) have no clinical symptoms; 2. female with age in 18-55 years old; 3. the maximum diameter of a single leiomyoma is less than 5m, and the number does not exceed 10 by mri; 4. no contraindications for sedation and analgesia; 5. patients and their families agree to join this study, and can follow up on time. exclusion criteria: 1. history of myomectomy, including transabdominal, laparoscopic, hysteroscopy, etc.; 2. history of connective tissue diseases or radiotherapy, especially abdominal radiotherapy; 3. with pregnancy, acute inflammation of the reproductive tract, or other gynecological benign and malignant diseases such as endometriosis and ovarian tumors; 4. the maximum diameter of leiomyoma is greater than or equal to 5cm; 5. suspected malignant tumor, such as sarcoma; 6. those with language communication barriers and unable to cooperate with sedative and analgesic programs; 7. abdominal scarring, when diagnosed by ultrasound transabdominal scan, has obvious sound attenuation (more than 10mm range).
effects of antimicrobial photodynamic therapy on regeneration of class ii furcation lesions

Conditions: Periodontitis, Chronic; Periodontal Diseases; Periodontal Bone Loss

Summary: the aim of this study is to evaluate the additional effect of antimicrobial photodynamic therapy regeneration treatment of mandibular furcation lesions when associated to bovine bone and porcine collagen membrane.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of class ii furcation lesion in mandibular 1st and 2nd molars * mandibular 1st and 2nd molars without caries, erosion or abrasion exclusion criteria: * smoking habit * pregnancy * use of antibiotics in the last six months * periodontal treatment in the last six months * endodontic lesion * systemic diseases that impair wound healing

Keywords: periodontal guided tissue regeneration photochemotherapy
evaluation of the changes in hiv-1 burden in peripheral blood and lymphoid tissue following zidovudine ( azt ) treatment in hiv-1-infected patients with cd4+ cells between 100 and 500 cells/mm3.

Conditions: HIV Infections

Summary: primary: to determine the effect of 8 weeks of zidovudine (azt) treatment on the hiv-1 burden in peripheral blood and lymphoid tissue in hiv-1-infected, azt-naive patients with cd4+ t lymphocyte counts between 100 and 500 cells/mm3. secondary: to determine the extent to which apoptosis (programmed cell death) occurs in these patients. in previous trials of azt treatment in hiv-infected patients, an antiviral effect has been clearly demonstrated by quantitative measurement of virus in plasma and peripheral blood mononuclear cells. however, the lymphoid tissues appear to be a major reservoir for hiv-1 and a major site of virus replication in hiv-infected persons. further data is needed to assess the effect of treatment on viral burden and hiv-1 replication in lymphoid tissue.

in previous trials of azt treatment in hiv-infected patients, an antiviral effect has been clearly demonstrated by quantitative measurement of virus in plasma and peripheral blood mononuclear cells. however, the lymphoid tissues appear to be a major reservoir for hiv-1 and a major site of virus replication in hiv-infected persons. further data is needed to assess the effect of treatment on viral burden and hiv-1 replication in lymphoid tissue. patients receive azt daily for 8 weeks and are followed in clinic at weeks 2, 4, 6, 8, 9, and 14 (or possibly via telephone call at week 14). patients undergo a lymph node biopsy at day 0 and week 8.

Eligibility criteria:
inclusion criteria concurrent medication: allowed: * prophylaxis against aids-related opportunistic infections. * supportive therapies, such as medications for nausea, vomiting, anemia, and analgesia. patients must have: * hiv infection. * cd4 count 100 - 500 cells/mm3. * at least two palpable lymph nodes. * plasma viremia. * no current aids-defining conditions. * no prior antiretroviral treatment. exclusion criteria concurrent medication: excluded during the first 8 weeks of study: * other antiretroviral agents. * steroids. * interleukins. * interferons. * cytotoxic chemotherapy. prior medication: excluded: * prior antiretroviral therapy. * prior cytotoxic chemotherapy. * acute therapy for an infection or another medical illness within 14 days prior to study entry.

Keywords: acquired immunodeficiency syndrome aids-related complex zidovudine lymph nodes lymphoid tissue
maintaining patency in implanted port catheters

Conditions: Obstruction; Catheter, Infusion Catheter (Vascular); Catheter; Complications (Indwelling Catheter)

Summary: the purpose of this study is to determine the safest and most effective flushing solution for maintaining patency (unobstructed flow) in implanted port catheters. the complication rate in patients whose ports are flushed with saline only will be compared to the complication rate in patients whose ports are flushed with a combination of saline and heparinized saline.

the purpose of this study is to determine the safest and most effective flushing solution for maintaining patency (unobstructed flow) in implanted port catheters. the complication rate in patients whose ports are flushed with saline only will be compared to the complication rate in patients whose ports are flushed with a combination of saline and heparinized saline. these complications include partial or complete obstruction, infection of the central line, and/or the onset of heparin induced thrombocytopenia.

Eligibility criteria:
inclusion criteria: * able to read and understand english * has an implanted port in place less than one (1) year * evidence of a patent (unobstructed) port catheter prior to enrollment in the study * is receiving active treatment (i.e., receiving a therapeutic drug through the implanted port) * current treatment protocol projected to continue for a minimum of three (3) months * anticipates receiving care at the identified centers for 12 months following enrollment in the study * does not receive care of implanted port at any other facility exclusion criteria: * has documented heparin platelet antibody (i.e., could not be randomized to either group) or other allergy to heparin * receiving therapeutic dose of an anticoagulant (e.g.,warfarin, heparin, enoxaparin) * does not have a bioflo port (heparinized port) * does not meet one or more of the inclusion criteria
epidemiological survey of hepatitis d virus infection in china

Conditions: Observe and Describe the Prevalence of Hepatitis D Infection Among HBsAg Positive People

Summary: this cross-sectional study will screen out hepatitis d virus-infected patients in hbsag-positive people. observe and describe the prevalence of hepatitis d infection among hbsag positive people. the provinces of china are divided into 5 geographical areas (north, south, east, west and central) to recruit patients according to the population density of each area. after statistical calculation, the total number of population needed is 3808.

entry criteria：1. age 18 years and above. 2. male or female. 3. diagnosed as chronic hbv infection (hbsag positive) 4.ability to sign informed consent. exclusion criteria：patients who disagree to participate in the trial. after the informed consent was signed, the quantitative data of the previous surface antigen or hbv dna titer was collected during the return visit. 4 ml of venous blood was collected on the same day or the remaining serum from the surface antigen or hepatitis b quantitative test was collected for the detection of hepatitis d antibody and/or the quantitative detection of hepatitis d rna. after statistical analysis, calculate the hepatitis d infection status in china.

Eligibility criteria:
inclusion criteria: * hepatitis b surface antigen or hbv dna positive exclusion criteria: * can't sign informed consent

Keywords: hbsag positive hbv dna
intraoperative low-dose ketamine infusion for patients with obstructive sleep apnea

Conditions: Sleep Apnea; Obstructive Sleep Apnea; Postoperative Complications

Summary: the aim of this study is to substantially reduce overall postoperative morbidity and mortality associated with obstructive sleep apnea.

obstructive sleep apnea (osa) affects millions of people in the u.s., and currently, there is not a well-established, general anesthetic technique that clearly decreases the risk of postoperative respiratory complications in these patients. if osa patients have significantly decreased postoperative opioid requirements and improved recovery profiles in the pacu, the protocol could have significant implications in defining future standardized general anesthesia recommendations for patients with this disease. ultimately, the aim of this study is to substantially reduce overall postoperative morbidity and mortality associated with obstructive sleep apnea. the objective of this study is to compare the postoperative recovery profile of osa patients receiving standard sevoflurane inhaled anesthesia with normal saline infusion versus sevoflurane combined with a low-dose ketamine infusion.

Eligibility criteria:
inclusion criteria: * aged 19-100 * scheduled to undergo general ent or orthopedic surgery * diagnosis of obstructive sleep apnea as confirmed by sleep study or deemed high risked for obstructive sleep apnea by clinical predictors (greater than 4 clinical predictors of obstructive sleep apnea as described by stop bang ). exclusion criteria: * positive pregnancy test * asa \> iii * history of alcohol or narcotic abuse in last 90 days * significant cardiovascular or respiratory disease (baseline oxygen saturation below 92%) * significant psychiatric or neurologic disease * history of significant hepatic or renal disease (baseline creatinine\>1.5) * history of allergy or contraindication to anesthetic agents or ketamine including patients with increased icp * increased iop * severe arrhythmias * history of delirium * history of hallucinations * history of psychosis * history of uncontrolled seizures * potential risk for malignant hyperthermia (family history) * history of difficult intubation that would preclude standard induction of anesthesia * prisoners * persons who are mentally impaired * non-english speakers

Keywords: ketamine postoperative morbidity
surgical management of giant hepatic hemangioma

Conditions: Liver Angioma

Summary: hepatic hemangiomas are the commonest benign mesenchymal lesions of the liver. most of these lesions are asymptomatic. giant hepatic hemangiomas (ghh) (\> 10 cm) are often symptomatic and require surgical intervention. this study aimed to describe the clinical findings, risk factors, diagnostic approach and management of ghh.

hepatic hemangiomas are the most common benign tumors of the liver with the incidence of 0.4 to 20% . they are most often discovered incidentally on imaging studies. typical hemangiomas usually do not increase in size over time and therefore are unlikely to cause symptoms. giant hepatic hemangiomas (ghh) are defined as hemangiomas larger than 5 cm . they are usually responsible for overt clinical symptoms and complications consisting, most often, of upper abdominal pain, hemorrhage, biliary compression, or a consumptive coagulopathy that may require prompt surgical intervention or other treatments . management of liver hemangiomas ranges from close observation to surgery depending upon the site, size and symptoms . it is widely accepted that intervention is indicated only for symptomatic hemangiomas. surgical resection is indicated in patients with abdominal complaints or complications, or when diagnosis remains inconclusive. the ideal surgical treatment for ghh is still controversial. enucleation is the preferred surgical method based on the existing literature. in this study, we report our 17-year experience of clinical management of ghh.

Eligibility criteria:
inclusion criteria: * radiological diagnosis of geant liver hamangioma. exclusion criteria: * radiological diagnosis of liver hemangioma less than 10cm.
saxagliptin and atherosclerosis

Conditions: Coronary Artery Disease; Diabetes Mellitus Type 2

Summary: dipeptidyl peptidase 4 (dpp-4) inhibitors are approved as add on therapy to improve glycaemic control in type 2 diabetes mellitus (t2dm). dpp-4 inactivates the incretin hormone glucagon-like peptide 1 (glp-1). inhibiting the inactivation of glp-1 leads to increased insulin- and reduced glucagon secretion after meals. dpp-4 has been shown to be present in atherosclerotic plaques. dpp-4 is a protease with substrates including cytokines and chemokines associated with atherosclerosis/inflammation. the purpose of this study is to explore the effects of 3 months intervention with dpp-4 inhibitor saxagliptin on biomarkers related to atherosclerosis in patients with stable coronary artery disease (cad) and t2dm, on circulating levels and on expression levels in circulating monocytes and adipose tissue. a reduction in markers associated with atherosclerosis could indicate an antiatherosclerotic effect of dpp-4 inhibitors beyond glycaemic control alone. due to reduced sample size (recruitment problems) the main focus has changed and will now be on cellular aspects and gene regulation (initially secondary outcome measure).


Eligibility criteria:
inclusion criteria: * patients \> 18, \< 80 years old, with type 2 diabetes mellitus and angiographically proven coronary artery disease. * hba1c \> 6.5% and under treatment with either metformin and/or glimepiride. exclusion criteria: * allergy or hypersensitivity to any of the drug's components. * heart failure in nyha class iii or iv. * severe liver failure, moderate or severe kidney failure * malignant disease. * active infectious disease. * acute coronary syndrome in the last 3 months. * pregnancy or breastfeeding.
a real-world observational study for the safety and efficacy of baraclude in korean pediatric patients with chronic hepatitis b

Conditions: Hepatitis B

Summary: this is a local, prospective observational study (regulatory post marketing surveillance) to access the safety and effectiveness of baraclude in korean pediatric patients with chronic hbv infection who are between the ages of 2 and less than 16 years.


Eligibility criteria:
inclusion criteria: * signed informed consent * 2 to \< 16 years of age * patients with chronic hepatitis b infection, eligible for treatment with baraclude as indicated in the locally approved prescribing information exclusion criteria: * off-label use of the approved label in baraclude pediatric indication * patients with a contraindication for the use of baraclude as described in the locally approved prescribing information other protocol defined inclusion/exclusion criteria could apply